Articles about fda

Pacemaker patch passes probe by US watchdog

It's probably the most crucial patch of the year: Abbott Laboratories' reworked firmware for its St Jude pacemakers has won the US Food and Drug Administration approval to ship. According to the regulator's statement, the upgrade should go smoothly, nearly all the time. Its statement says “installing the updated firmware …
Beavis and Butt-Head

Authorities go hard on coffee maker for stiff Viagra-powered brew

How's this for a stiff one to start the day? We now go live to America, where watchdogs have recalled a batch of coffee for containing an active ingredient very similar to Viagra. The US Food and Drug Administration says the mysterious boner-brew originated from BestHerbs Coffee LLC, and was labeled as "New of Kopi Jantan …
Shaun Nichols, 21 Jul 2017

IBM: Hm, medical record security... security... Got it – we need blockchains

IBM says it will partner with the US Food and Drug Administration (FDA) on a study of whether blockchain technology could be used to securely transfer medical information. Big Blue says that its Watson Health unit will work with the FDA on a study aimed at pitching a framework for the use of blockchain technologies to make the …
Shaun Nichols, 12 Jan 2017

St Jude patching Merlin@home heart kit

Months after steadfastly denying its heart implants have serious security vulnerabilities, St Jude – now owned by Abbott Laboratories – has issued a patch. The company's press release is here. Last year, a pentester and an investor pulled a now-notorious double act on St Jude, shorting its stock before publishing the …

Now the Olympics is over, Theranos is withdrawing its Zika test application

Now that the Olympics is over, there's no apparent athlete-borne Zika pandemic, and the virus doesn't guarantee a headline, Theranos has withdrawn its emergency application to have the Food and Drug Administration approve its blood test for the virus. The emergency approval would have let the company pitch its wares as a Zika …

Why does herbal cough syrup work so well? It may be full of morphine

The US Food and Drug Administration (FDA) is sounding alarms after an herbal cough remedy sold throughout the US was found to contain morphine. The FDA said that bottles of Licorice Coughing Liquid made by Chinese-based Ma Ying Long Pharmaceutical Group and distributed by Master Herbs, Inc contain a "camphor compound" whose …
Shaun Nichols, 21 Jan 2016

US publishes guide to hardening your arteries, security-wise, that is

The US Food and Drug Administration has issued draft guidance requiring medical device manufacturers to up their security game and report major incidents to the agency. Organisations building pacemakers, defibrillators, insulin pumps, and other hackable medical systems will need to be able to identify; protect; detect; respond …
Darren Pauli, 19 Jan 2016

FBI, US g-men tried to snatch DNA results from blood-testing biz. What a time to be alive

+Comment Not content with snooping on your emails, whereabouts and telephone calls, it appears the Feds now want your DNA results. DNA testing company 23andMe says it has received four requests from law enforcement agencies for "user data" in the past quarter, all of them from the United States. Those stats came in the first " …
Kieren McCarthy, 21 Oct 2015

Stop taking drug advice from Kim Kardashian on Twitter, sighs watchdog

Robert Dean may be questioning his career decisions. The division director of US drug regulator the FDA has warned the public that Kim Kardashian's social network pages are not a particularly reliable source of medical advice. In an open-letter [PDF], Dean said endorsements from celebrity buttocks Kardashian were misleading …
Shaun Nichols, 12 Aug 2015
Spritam 3D printed pills

Screw your cutesy plastic art tat, the US govt has found a use for 3D printing: DRUGS!

The US Food and Drug Administration (FDA) has granted its first-ever approval for a drug manufactured by 3D printing. The FDA told Aprecia Pharmaceuticals it could move forward [PDF] with the introduction of Spritam, an anti-seizure medication for people with epilepsy. The pill is set to go on sale in the US early next year. …
Shaun Nichols, 4 Aug 2015

This hospital drug pump can be hacked over a network – and the US FDA is freaking out

The US Food and Drug Administration has told healthcare providers to stop using older drug infusion pumps made by medical technology outfit Hospira – because they can be easily hacked over a network. "Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a …
Iain Thomson, 1 Aug 2015
Snake oil salesman

Seriously, stop claiming your two-buck photo app can detect cancer

The US Federal Trade Commission (FTC) has reached a final settlement with an app developer accused of misleading people into believing its software could detect skin cancer. The commission said Health Discovery Corporation, the makers of the $1.99 MelApp application for iPhones, will no longer be able to claim that it can …
Shaun Nichols, 13 Apr 2015

Boris Johnson backs trade union campaign to ungag civil servants

Boris Johnson and the FDA trade union are calling for the government to lift new restrictions on civil servants' contact with the media, which was quietly implemented following an update to the Civil Service Code slipped through earlier this month. The addition to the Civil Service Code earlier this month requires that all …
Obama and Silicon Valley dinner, Official White House Photo by Pete Souza

Google and Obama: You’re too close for comfort

+Comment It’s five years since I compared Google to Halliburton, the defence contractor that received large contracts from the Bush Administration, and whose former boss was George W Bush's righthand-man Dick Cheney. Today that comparison looks horribly unfair – unfair to Halliburton. The Wall Street Journal has revealed America's …
Andrew Orlowski, 21 Mar 2015
Samsung Gear Fit

FDA draws line between wearable health gizmos and proper medical gear

The US Food and Drug Administration (FDA) has published draft rules for wearable gadget makers to follow if they want their stuff classified as "general wellness" devices by the watchdog. By "general wellness", the regulator means monitoring basic things like heart rates and distances walked each day, as opposed to vital …
Shaun Nichols, 20 Jan 2015
Neal's Yard introduces its 'Green Scientists'

Homeopathic remedies contaminated with REAL medicine get recalled

A batch of homeopathic remedies have been recalled in the US after it was discovered that they contained real medicine. Terra-Medica is voluntarily recalling 56 lots of homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms after it was discovered the alternative treatments potentially contained …
John Leyden, 28 Mar 2014
DNA

Bad genes? US watchdog halts 23andMe's handy home DNA test kits

Vanity DNA testing company 23andMe has hit a major roadblock, having been told by the US Food and Drug Administration (FDA) that it must stop selling its personal genome testing kits. Backed by Google and run by Anne Wojcicki, the estranged wife of Google cofounder Sergey Brin, 23andMe has marketed its Saliva Testing Kit and …
Neil McAllister, 25 Nov 2013

Medical apps to come under FDA scrutiny

In a move that's sure to be watched closely by medical regulators worldwide, America's Food & Drug Administration (FDA) has issued its final regulatory guidance on regulating medical apps running on smartphones. The announcement formalises a draft guidance issued in July, the culmination of a long process under which 100 apps …

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